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      Individualizing the Oncological Treatment of Patients With Metastatic Non–Clear Cell Renal Cell Carcinoma by Using Gene Sequencing and Patient-Reported Outcomes: Protocol for the INDIGO Study


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          No phase 3 studies have yet been conducted for patients with non–clear cell (CC) renal cell carcinoma (RCC) exclusively due to the rare occurrence of the disease and the heterogenicity in tumor morphology. Consequently, there is no evidence of the optimal treatment, and new approaches are needed. One approach is individualizing treatment based on the gene sequencing of tumor tissue. Additionally, recent studies involving the patient-reported outcomes (PROs) of patients treated for metastatic cancer have shown significant benefits for quality of life, median overall survival, and overall survival. The use of gene sequencing and PROs can be of great importance to patients with rare cancer types, including patients with non-CC RCC, and should be investigated in clinical trials, especially for cases where evidence based on phase 3 studies is difficult to obtain.


          We describe the INDIGO study, in which patients, based on gene analyses, will be allocated into 4 treatment arms containing 14 treatments and use electronic PROs. We aim to improve the treatment of patients with non-CC RCC. The end points in the study will be the overall response rate (complete and partial) in the total patient population, which will be based on the RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 criteria, and the time to treatment failure.


          INDIGO is a prospective phase 2 trial, and 30 patients will be enrolled. The patients will receive systemic treatment based on genetic analyses of their tumor tissue. All patients will receive electronic questionnaires in a dedicated app—a questionnaire regarding symptoms and side effects and another regarding health-related quality of life. Depending on the treatment regimen, the patients will be seen by a medical doctor every third, fourth, or sixth week, and the effect of the systemic treatment will be evaluated every 6 weeks via a computed tomography scan. The study has been approved by the Danish Medicines Agency and the National Committee on Health Research Ethics (approval number: H-19041833), complies with good clinical practice guidelines, follows the General Data Protection Regulation, and is registered at the Capital Region of Denmark.


          Recruitment started in March 2020, and at the time of submitting this paper (June 2022), a total of 9 patients have been enrolled.


          We aim to explore methods for improving the treatment outcomes of patients with non-CC RCC, and the INDIGO study will contribute further data on personalized medicine for rare types of RCC and provide new knowledge on the active use of electronic PROs.

          Trial Registration

          ClinicalTrials.gov NCT04644432, https://clinicaltrials.gov/ct2/show/NCT04644432 ; European Union Drug Regulating Authorities Clinical Trials Database 2019-001316-38, https://tinyurl.com/2p8mb4aw

          International Registered Report Identifier (IRRID)


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          Most cited references27

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          Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma

          Nivolumab plus ipilimumab produced objective responses in patients with advanced renal-cell carcinoma in a pilot study. This phase 3 trial compared nivolumab plus ipilimumab with sunitinib for previously untreated clear-cell advanced renal-cell carcinoma.
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            Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma

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              Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial.

              There is growing interest to enhance symptom monitoring during routine cancer care using patient-reported outcomes, but evidence of impact on clinical outcomes is limited.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                September 2022
                15 September 2022
                : 11
                : 9
                : e36632
                [1 ] Department of Oncology Copenhagen University Hospital Herlev Herlev Denmark
                [2 ] Department of Clinical Medicine University of Copenhagen København Denmark
                [3 ] Department of Oncology Rigshospitalet København Denmark
                Author notes
                Corresponding Author: Ida Marie Lind Rasmussen ida.marie.lind.rasmussen@ 123456regionh.dk
                Author information
                ©Ida Marie Lind Rasmussen, Anne Vest Soerensen, Anne Kirstine Møller, Gitte Fredberg Persson, Jesper Andreas Palshof, Gry Assam Taarnhøj, Helle Pappot. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 15.09.2022.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 19 January 2022
                : 29 March 2022
                : 19 May 2022
                : 13 June 2022

                patient-reported outcome,electronic patient-reported outcome,renal cell carcinoma,non–clear cell renal cell carcinoma,health-related quality of life,oncology,targeted therapy,precision medicine,ehealth,outcome,patient-reported


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